Kornimate/medical-research-clean huggingface dataset:
acetylcysteine, theophylline, and a combination of both in the prophylaxis of contrast-induced nephropathy

Conditions: Contrast Induced Nephropathy; Kidney Diseases; Renal Failure; Adverse Effects

Summary: several studies demonstrated a significant reduction of contrast-induced nephropathy (cin; definition: increase in serum creatinine of \>=0.5mg/dl and/or \>=25% increase within 48h after contrast-medium) by acetylcysteine (a) or theophylline (t). however, the results are contradictory. therefore, it was the aim of our double-blind study to compare the effects of a, t, a combination of a and t (a+t), and placebo (p).

contrast-induced nephropathy (cin) is the third leading cause of hospital-acquired acute renal failure (arf). accounting for 12% of arf cases, cin is defined as an increase of serum creatinine of at least 0.5 mg/d ("barrett´s definition") and/or 25% within 48 hours of contrast-medium application. cin is associated with prolonged hospitalisation and increased mortality. cin frequency depends on several risk-factors including pre-existing renal dysfunction, high amounts of contrast-medium, diabetes, and concurrent use of nephrotoxic drugs. cin incidence is low in the absence of risk-factors; however, in high-risk patients, cin occurs in more than 50% of patients. a variety of prophylactic approaches have been investigated. despite nephro-protective effects of hydration with saline or with sodium bicarbonate, other trials reported cin-incidences between 20 and 50% despite hydration. several studies and two recent meta-analyses demonstrated a significant reduction of renal impairment after contrast-medium using medical prophylaxis with the adenosine antagonist theophylline. however, a recent trial failed to prove prophylactic effects of theophylline. the antioxidant acetylcysteine (acc) was effective in patients with impaired renal function in at least six studies, but it was not preventive in at least 21 trials and two recent meta-analyses. a recent study comparing the prophylactic efficacy of theophylline and acetylcysteine demonstrated superior prophylactic effects of theophylline. nevertheless, this study did not include a placebo group, was not restricted to patients with impaired renal function and exclusively enrolled icu-patients. therefore, we performed a double-blinded study to compare the effects of acetylcysteine, theophylline, a combination of both, and placebo in patients with impaired renal function (serum creatinine \>=1.3mg/dl) parenterally receiving \>=100ml of contrast-medium.

Eligibility criteria:
inclusion criteria: * impaired renal function (serum creatinine \>=1.3mg/dl) * \>=100ml of contrast-medium * age \>= 18years * informed consent exclusion criteria: * previous dialysis and/or haemofiltration * pre-treatment with acetylcysteine and/or theophylline within the last 2 days, * pregnancy * contraindications to theophylline (untreated high grade arrhythmia or a history of seizures) or acetylcysteine (known allergy).

Keywords: contrast induced nephropathy prophylaxis theophylline acetylcysteine coronary angiography
phase ii clinical trial for the evaluation of the efficacy of transanal tme

Conditions: Rectal Cancer

Summary: the purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision.

subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. transanal visualization will be using endoscopy. at the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.

Eligibility criteria:
inclusion criteria: 1. age: 20-80 years 2. biopsy-proven adenocarcinoma of the rectum 3. clinical staging (c or yc): t0-3, n0-2, m0 4. rectal cancer located 3-12 cm from the anal verge 5. ecog performance status: 2 or less 6. bmi: less than 30 exclusion criteria: 1. synchronous colon cancer or other malignancy 2. obstructing rectal cancer 3. pregnant or breast-feeding 4. receiving any other study agents 5. fecal incontinence 6. history of prior colorectal cancer or inflammatory bowel disease 7. tumor size: more than 7cm in long diameter 8. crm: mesorectal fascia involvement or less than 1 mm on mri

Keywords: transanal tme quality crm
r-5780-01 in combination with pd-1 checkpoint inhibitors (checkpoint protein on immune cells called t cells) in patients with solid tumors

Conditions: Solid Tumor, Adult; Solid Tumor; Melanoma; Basal Cell Cancer; Squamous Cell Cancer; Adenoma

Summary: the goal of this study is determine the safety and tolerability of orally taken probiotic (r-5780) in patients currently on a pd-1 pathway checkpoint inhibitor (checkpoint protein on immune cells called t cells) with solid tumors.

patients will take an oral dosage of probiotic (r-3750 and provide patient reported overall feeling and physician scored measure of their tumors. blood and fecal evaluations of inflammation and assessment of probiotic (r-5780) on fecal levels will also be measured.

Eligibility criteria:
inclusion criteria: * at least 18 years of age to 80 * ability to provide written informed consent * unresectable stage iii or stage iv melanoma, basal cell carcinoma, or squamous cell carcinoma as per the american joint committee on cancer 2017 guidelines (8th edition) regardless of braf mutation status and other solid tumors. * refractory to anti-pd (checkpoint protein on immune cells called t cells)-1/l1 therapy per recist v1.1 defined as subject who has disease progression after receiving at least two complete cycles of ici (immune checkpoint inhibitors) therapy or disease progression 6 months from initiation of ici (immune checkpoint inhibitors) therapy while still on active therapy. * life expectancy of greater than 3 months * eastern cooperative oncology group (ecog) performance status of 0, 1 or 2 * subjects must have evaluable disease by ct (computer tomography) or mri (magnet resonance imaging) per recist 1.1 criteria or clinically apparent disease that the investigator can follow for response. exclusion criteria: * any serious medical condition or laboratory abnormality or psychiatric condition or any other significant or unstable concurrent medical illness (in the opinion of the investigator) would preclude protocol adherence or would make the safety of the study drug difficult to assess * treatment with systemic broad-spectrum antibiotics. * no active viral infections. * coexisting severe chronic diseases other than cancer (autoimmunity, inflammatory diseases) * secondary gastrointestinal motility disorders * history of solid organ transplant or bone marrow transplant * prior car-t (chimeric antigen receptor) or allogeneic cellular therapy * ongoing systemic immunosuppressive therapy, with the exclusion of prednisone (10 mg/day) * concurrent therapy with any other investigational agent, vaccine, or device * pregnant or breastfeeding or planning to conceive or father a child during the trial period * subjects with untreated brain metastasis. treated brain metastasis are permitted if stable * more than 4 prior systemic therapies * other cancer medications during treatment period are not permitted * enrollment in other clinical trials.

Keywords: solid tumors
minimally invasive techniques for treating large proximal ureteral stones

Conditions: Endourology

Summary: a prospective comparative study designed to compare the outcomes of transperitoneal laparoscopic ureterolithotomy (t-lul), mini-percutaneous antegrade ureteroscopy (a-urs) and retrograde ureteroscopy (r-urs) in treating patients with lpus (15-20 mm). the following parameters were assessed and compared (demographic data and stones characteristics, stone free rate and complications)

we aimed in the current study to comprehensively evaluate and to compare the outcome of transperitoneal laparoscopic ureterolithtomy, retrograde ureteroscopy and mini-percutaneous antegrade ureteroscopy for management of large proximal ureteric stone (15 -20 mm) with regards to; operative time, stone free rate, success rate, hospital stay and complications. a total of 105 participants were enrolled in the trial between april 2021 and june 2023 to accomplish this. inclusion criteria for this study included patients who had a single proximal ureteral stone (between the pelvi ureteric junction and the upper border of the sacroiliac joint) measuring 15-20 mm in diameter. patients were randomly allocated to receive either tplu, rurs, or minin-perc antegrade urs, with a 1:1:1 allocation ratio. after providing informed permission, the patients were randomly assigned to one of three groups: group i (35 patients treated with tplu), group ii (35 patients treated with rurs), and group iii (35 patients not treated with either tplu or rurs) (included 35 patients who were treated by mini-perc antegrade urs)

Eligibility criteria:
inclusion criteria: * adults patients * large proximal ureteral stones(1.5-2 cm) exclusion criteria: * larger stones * multiple stones * bleeding tendency * active uti * distal stricture
volumetric study of the buttocks after flap augmentation in buttocks lifting

Conditions: Weight Loss

Summary: the development of bariatric surgery, its effectiveness and the reduction of complications are at the origin of massive weight loss, the corollary of which has been a clear increase in the demands of treatment of sequelae of weight loss.


Eligibility criteria:
inclusion criteria: * 12 months minimum delay with bariatric surgery * female, bmi\<30kg/m2 * age greater than or equal to 18 years * stable weight for more than 6 months * lack of volume in gluetal region * agree with clinical trial exclusion criteria: * patient under tutorship or curatorship * pregnancy or breastfeeding * hemoglobinemia\< 12g/dl * albuminemia\<3,5g/dl * active smoking more than 1 month before surgery

Keywords: plastic and reconstructive surgery gluteal ptosis platipygia
effects of subanesthetic isoflurane/sevoflurane in 60% oxygen on clinical in-vitro experimental sepsis

Conditions: Sepsis

Summary: sepsis is a major cause of death in intensive care units. despite the investigators improved understanding, which has reduced the risk of dying with sepsis, the number of people who die each year continues to increase due to an overall increase in the number of cases.in our previous study, the investigators have showed that 100% oxygen or 0.5 minimum alveolar concentration (mac) isoflurane/sevoflurane in 60% oxygen protect mouse macrophage cell line against in-vitro sepsis induced by lipopolysaccharide (lps). in this study, the investigator hypothesized that treatment of 100% oxygen or 0.5 mac isoflurane/sevoflurane in 60% oxygen protected against clinical in-vitro models of sepsis induced by lps or plasma from septic patients.

100% oxygen or 0.5 mac isoflurane/sevoflurane in 60% oxygen would inhibit increases of tumor necrosis factor (tnf)-alpha, interleukin-1beta, interleukin-6 in the cell culture supernatant after stimulation of lps or plasma from septic patients, and also inhibit the nuclear location of nuclear factor-kappa b p65 subunit.

Eligibility criteria:
inclusion criteria: * human pbmcs were only isolated from the adult patients without sepsis/sirs/infectious diseases. * the plasma for induction of clinical in-vitro sepsis, was only isolated from adult patients with sepsis. exclusion criteria: * patients who had been selected for other clinical trials in the 3 months before.
growth and safety of two partially-hydrolyzed feeding systems for preterm infants

Conditions: Pre-term Infant

Summary: this is an open-label trial consisting of two sub-studies to be conducted sequentially with the purpose of evaluating the safety and suitability of a two feeding systems in pre-term infants (one containing hmos and one without hmos).

this is a multi-center, open-label trial to be conducted in up to 70 pre-term infants in order to evaluate the safety and suitability of two feeding systems as they would typically be used in the neonatal care unit. growth (in comparison to recommended growth goals), feeding tolerance, biochemical parameters, and adverse event reporting will be evaluated. the two feeding systems will be tested in two sub-studies to be conducted sequentially: sub-study 1 will evaluate a two-staged feeding system with hmos in up to 35 pre-term infants; sub-study 2 will evaluate a two-staged feeding system without hmos in up to 35 pre-term infants. a follow up period from 12 to 24 months have been added to the study protocol, to assess the neurocognitive development of the subjects during this period.

Eligibility criteria:
inclusion criteria: 1. written informed consent has been obtained from one or both parent(s) /legally acceptable representative (lar) in accordance with local regulation. 2. infants' birth weight ≤1500 g and aga. 3. infant's gestational age \< 37 weeks. 4. infant is clinically stable and does not have deteriorating respiratory function after birth. 5. infant is eligible to start experimental formula after 24 hours of trophic feeding, but still within the first 10 days (≤240 hours) of life. exclusion criteria: 1. parent(s) not willing / not able to comply with the requirements of study protocol. 2. infant is experiencing early onset sepsis. 3. major congenital or chromosomal abnormality known to affect growth. 4. liver failure. 5. peri-/intra-ventricular haemorrhage (grade 3-4 in papille classification). 6. infant who has siblings with diagnosed allergies or intolerances to lactose or cow's milk. 7. infant's participation in another interventional clinical trial. 8. infant has already achieved fef prior to enrolment, using the definition accepted by neonatal unit as per standard practice (150 ml/kg/day).
hcv related hepatocellular carcinoma recurrence after directly acting antivirals: a randomized controlled trial

Conditions: Hepatocellular Carcinoma; Hepatitis C; Neoplasm Recurrence; Treatment Complication

Summary: data regarding hepatocellular carcinoma (hcc) recurrence after directly acting antivirals (daas) given for hepatitis c virus treatment are contradictory. surprisingly, some studies reported that daas are accompanied with higher hcc recurrence. but, other studies showed no rise or even decrease in hcc recurrence. most of these studies were retrospective and some were non-randomized prospective studies. here investigators aim to perform a randomized controlled trial to study this issue.


Eligibility criteria:
inclusion criteria: * child-pugh a and b subjects with hepatitis c related \< 5 cm single or up to 3 hepatocellular carcinomas without any vascular or extrahepatic involvement exclusion criteria: * those with positive hbsag, history of alcohol consumption, patients with other known causes of chronic liver disease, patients who have received previous daas for hcv and patients who have received previous locoregional treatment for hcc will be excluded.
lacosamide iv and eeg/ekg (live) study

Conditions: Focal Epilepsy

Summary: the purpose of this study is to evaluate the effect of different intravenous doses (iv) of a new anti-epileptic drug (aed) called lacosamide on continuous eeg (electroencephalogram) rhythms (or brain rhythms) in subjects with focal seizures and the tolerability of those doses by patients. in addition, this study will assess the effect of iv lacosamide on ekg (electrocardiogram), a test which checks for problems with the electrical activity of the heart.

the impact of antiepileptic drugs on the eeg can vary from marked to none. a small number of aeds also affect the ekg. lacosamide is a new aed that selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing. information is lacking about the effect of lacosamide on brain and heart rhythms.

Eligibility criteria:
inclusion criteria: 1. subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent. 2. adult patients 18-65 years 3. diagnosis of focal epilepsy 4. continuous eeg and video monitoring 5. continuous ekg 6. active eeg showing frequent spikes, electrographic or clinical seizures exclusion criteria: 1. subject has no iv access. 2. subject is hemodynamically unstable. 3. previous use of lacosamide 4. primary generalized epilepsy 5. non-epileptic seizures 6. no significant cardiac, renal or hepatic disease 7. no cardiac arrhythmias including heart block 8. subject is a pregnant or lactating woman.

Keywords: iv lacosamide focal epilepsy eeg ekg
iron metabolism in dragon boat athletes

Conditions: Anaemia

Summary: the purpose of the study is: * to investigate the effect of sport-specific stress in the iron metabolism of dragon boat athletes * to investigate the effects of sport-specific stress in the activity of pro-hepcidin and hepcidin

this investigation evaluates the effects of sport-specific stress in iron metabolism of dragon boat athletes. recent studies showed a significant increase in hepcidin activity under exercise (röcker l. et al.(2005): iron regulatory protein hepcidin is increased in female athletes after a marathon. european journal of applied physiology, s. 95, 569-571)which possibly influences the iron metabolism. in particular in this investigation the activity of pro-hepcidin and hepcidin under sport-specific stress is analysed. therefore elite dragonboat athletes will be included to this study. every athlete is tested once. at one exercise day from every athlete the iron metabolism especially the change of hepcidin, prohepcidin and iron before and after a specific dragonboat intervention is analysed.

Eligibility criteria:
inclusion criteria: * athletes performing dragon boat sport exclusion criteria: * acute clinically significant intercurrent diseases

Keywords: iron metabolism hepcidin dragon boating sport-specific stress iron anaemia sport
brain-behavior interactions in tic suppression

Conditions: Tourette's Syndrome; Chronic Motor Tic Disorder; Chronic Vocal Tic Disorder

Summary: the purpose of this study is to examine how the brain and environment interact to influence children's ability to suppress tics using a medical technology called transcranial magnetic stimulation (tms).

objectives: this study will recruit youth with chronic tics. chronic tics are the most common movement disorder in children. the goal of the study is to learn how the brain and environment influence children's ability to suppress tics. specifically, we want to learn how tics are influenced by a certain part of the brain called the supplementary motor area (sma). this part of the brain is thought to be more active in people with tics. this will be the first study to look at the relationship between sma, tic suppression, and urges to tic. research procedures: the study will take place over the course of three days within a week (about 5 hours total). the study will examine the relationship between the sma and tic suppression using a non-invasive medical technology called transcranial magnetic stimulation (tms). participants will have a diagnostic interview, mri brain scan (used to find the location of the sma), and tms. participants will be asked to try to suppress tics before and after tms. the information that will be collected from participation includes information about tic symptoms, emotional and behavioral functioning, and brain activity (from mri brain images and tms results).

Eligibility criteria:
inclusion criteria: * presence of motor and/or vocal tics for at least one year * english fluency exclusion criteria: * participants with medical conditions that are contraindicated for tms (history of any known intracranial pathology, epilepsy or seizures, traumatic brain injury, brain tumor, stroke, implanted medical devices, current pregnancy or girls of childbearing age not using effective contraception, or any other serious medical conditions * left-handedness * previous diagnosis of psychosis, autism spectrum disorder, mental retardation, or cognitive disability * inability to undergo mri * substance abuse or dependence within the past year * history of ≥3 sessions of habit reversal therapy or other treatment primarily comprised of tic suppression strategies * current suicidal intent * current neuroleptic medications, as these medications are known to lower seizure threshold
the bottle study: infant weight gain during use of novel versus typical infant feeding bottles

Conditions: Infant Feeding Behavior

Summary: the purpose of this study is to pilot test whether a novel infant feeding bottle changes how much formula an infant drinks and how quickly he/she drinks it, as compared to meals provided in a standard bottle. exclusively formula-fed infants and their caregiver will be provided with the novel feeding bottle and caregivers will be asked to acclimate their infant to this bottle during the next several weeks. once acclimated, infants will undergo two weighed, timed, and videotaped test meals on two separate days; one with the novel bottle and one with their standard bottle, in random order. it is hypothesized that when the novel bottle is used, infants bottle will consume smaller meals and will have a longer meal duration, as compared to when a standard bottle is used.


Eligibility criteria:
inclusion criteria: * healthy, exclusively formula-fed infants aged 1-6 months at enrollment; * parent must be at least 19 years of age, able to understand written and verbal english, and provide daytime care for the infant at least 4 days per week. exclusion criteria: * born \< 37 weeks; * birth weight \ 4000g; * current weight \< 10th percentile for age; * hospitalization \> 72 hours following birth or any hospital admission since birth; * any health issue that could interfere with feeding and/or growth; * use of complementary foods; * inability or unwillingness to comply with study-related procedures.

Keywords: intake formula feeding
beer, marathon, genetics, inflammation and the cardiovascular system: be-magic-trial

Conditions: Inflammation; Heart Failure; Sudden Cardiac Death

Summary: the purpose of the study is to determine the myocardial function and vascular adaptation after strenuous exercise in association with consumption of polyphenols. the investigators aim to investigate the effects of extreme endurance exercise on the inflammatory system. furthermore, the role of the cardiovascular response and adaptive mechanisms of the vasculature are examined. subclinical injuries to the myocardium and vascular wall are being investigated.

regular exercise leads to an improvement of cardiovascular risk factors in patients with coronary heart disease, atherosclerosis and metabolic disorders. aerobic exercise has anti-inflammatory effects. in contrast, the exertional exercise of marathon running causes an acute pro-inflammatory impulse. this may lead to myocardial injury and, in case of preexisting plaques, may result in plaque rupture and acute myocardial infarction. we aim to define the critical role of inflammatory markers and cardiovascular risc factors as a predictor of an increased risk for myocardial and endothelial dysfunction in marathon runners. diagnostic tools include measurements of microvasculature, the large vessels and echocardiography. inflammatory markers include high sensitive c-reactive protein (crp) and interleukins. all variations are analysed on the basis of consumption of polyphenols as they are found in in hops (humulus lupus l.) and beer.

Eligibility criteria:
inclusion criteria: * men aged 20-60 years exclusion criteria: * manifested heart disease * insulin dependent diabetes mellitus * multi drug therapy * gfr \< 60 ml/min * smokers * neoplasia * (former) alcoholism * known malabsorption * known chronic inflammatory disease